Bristol Myers Squibb and AstraZeneca Pharmaceuticals LP are facing a new Onglyza lawsuit, which was filed by a couple alleging the plaintiff developed congestive heart failure symptoms. The Onglyza lawsuit alleges the husband had developed congestive heart failure symptoms soon after starting his prescription.

Plaintiff couple Wiley and Rhudenia W. conjointly filed this Onglyza lawsuit, alleging Bristol Myers and AstraZeneca failed to warn them to look out for dangerous side effects, like potential congestive heart failure symptoms. Like millions of other patients, Wiley had been prescribed Onglyza to treat his type-2 diabetes and help manage his symptoms.

Onglyza is a part of the incretin mimetic drug class, which works by increasing the amount of insulin in the blood. Without sufficient insulin levels, the body becomes unable to metabolize sugar and is forced to metabolize fat. This makes the blood become very acidic and causes a buildup of ketones, or blood acids, which can quickly become fatal.

Without sufficient insulin levels patients can develop diabetic ketoacidosis or kidney failure, which can become fatal. Onglyza and other type-2 diabetes medications are supposed to prevent this condition and other diabetic symptoms, allowing patients to live a normal life.

Onglyza

Wiley and Rhudenia allege Bristol Myers and AstraZeneca marketed Onglyza as a safe and effective treatment medication for type-2 diabetes, without mentioning potential congestive heart failure symptoms.

With these benefits in mind, Wiley agreed to start his Onglyza prescription in November 2012 and stayed on the medication until May 2013. However, not long after his prescription ended, Wiley reportedly experienced alarming congestive heart failure symptoms.

According to the Onglyza lawsuit, Wiley had developed congestive heart failure by June 4, 2013. Wiley opted to file legal action against AstraZeneca and Bristol Meyer Squibb after discovering other Onglyza patients may have suffered the same fate.

Overview of Onglyza Heart Failure

Onglyza was approved by the FDA in July 2009 to be a treatment medication for type-2 diabetes, but it has become associated with a number of serious side effects including potential heart failure.

One of the most significant studies showing this correlation was published in 2013 in the New England Journal of Medicine. This SAVOR study consisted of 16,492 type-2 diabetes patients; researchers evaluated whether or not Onglyza was the right medication for study subjects.

Researchers found that Onglyza patients faced a higher rate of hospitalization for heart failure, compared to other type-2 diabetes medications.

While these results were not considered statistically significant, it still raised concern in the medical community of a potential correlation.

In April 2015, an FDA advisory committee stated the agency should require AstraZeneca and Bristol Myers Squibb to require heart failure symptoms or heart failure risk be included on Onglyza’s warning label.

Heart failure is a potentially fatal condition, in which the cardiac muscle becomes too weak to circulate blood. Even though heart failure is a potentially fatal condition, plaintiffs claim AstraZeneca and Bristol Myers allegedly failed to warn patients against congestive heart failure symptoms.

At all times relevant, Wiley and Rhudenia say they relied on the Onglyza marketing statements and product information provided by AstraZeneca and Bristol Myers Squibb. Wiley claims he followed all prescription instructions and physician’s advice, but still suffered serious complications.

This Onglyza Lawsuit is Case No. 3:18-cv-00082-TCB, in the U.S. District Court of Northern Georgia, Newman Division.